JOB DESCRIPTION:

The Director/Senior Director, Regulatory Affairs Advertising and Promotion will play a critical role in enabling the achievement of Kura business objectives by ensuring compliance with governing laws, regulations, and internal policies and procedures. This role will be responsible for review and approval of U.S. promotional and non-promotional materials and will serve as the primary liaison to FDA Office of Product and Drug Promotion (OPDP). This individual will provide commercial regulatory strategic and operational leadership to cross-functional teams.

Reporting to the Head of Regulatory Affairs, this role will lead the development of processes and policies and establish commercial regulatory infrastructure in support of Kura’s evolution into a commercial organization. This role requires a deep understanding of industry regulations, excellent leadership skills and the ability to work cross functionally to drive regulatory strategies.

ESSENTIAL JOB FUNCTIONS:

• Ensure U.S. advertising and promotional materials comply with applicable regulatory requirements, standards, and guidelines across all products.
• Serve as the Regulatory Reviewer and/or chair on promotional review committees and boards.
• Collaborate with colleagues in Commercial, Medical Affairs, Legal, and Compliance to incorporate regulatory considerations into promotional and non-promotional materials, including the creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange.
• Provide creative guidance from a Regulatory perspective on the development of product messages and materials.
• Conduct risk assessments of U.S. promotional campaigns, providing guidance on potential regulatory risks and developing mitigation strategies.
• Serve as primary liaison for the FDA Office of Prescription Drug Promotion (OPDP) for assigned products and ensure timely and accurate submissions of promotional materials.
• Serve as an internal subject matter expert and provide strategic and operational commercial regulatory guidance to internal stakeholders on U.S. Advertising & Promotion issues including scientific exchange.
• Monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, and scientific exchange, and analyze and communicate their relevance to Kura.
• Drive continuous improvement initiatives within the regulatory affairs function, optimizing processes to enhance efficiency and effectiveness in managing advertising and promotional compliance.

JOB SPECIFICATIONS:

• BS/BA degree; advanced degree desirable but not required.
• Minimum 10 years pharmaceutical/biotechnology industry experience, 5 years in a U.S. advertising and promotion role.
• Advanced knowledge of U.S. advertising promotion regulations and scientific exchange provisions with proficient technical knowledge in aspects of drug development and labelling.
• Advanced experience with promotional and medical review supporting product communications, liaising with FDA (OPDP) on advertising and promotion matters, and managing regulatory submissions of promotional materials for marketed prescription drug products.
• Experience serving as the Regulatory Reviewer and/or chairing promotional review committees or other relevant regulatory governance committees.
• Experience with Veeva PromoMats a plus.
• Experience with product launches in the hematology/oncology and/or rare disease areas a plus.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
• Excellent written and verbal communication skills, with demonstrable proficiency in understanding and communicating scientific, medical and legal concepts and information.

The base range for a Director, Regulatory Affairs is $220,000 - $240,000 and Senior Director, Regulatory Affairs is $262,000 - $295,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus